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Safety, Efficacy and Pharmacokinetic Study of Allegra in Pediatric Patients With Atopic Dermatitis (AD)

NCT ID: NCT01244230

Last Updated: 2013-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-08-31

Brief Summary

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Primary Objective:

To evaluate safety (4 weeks)

Secondary Objectives:

* To evaluate the long-term safety (12 weeks)
* To evaluate the efficacy
* To characterize the pharmacokinetic profile

Detailed Description

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The study consists of four phases: up to 9-day screening phase, main 4-week treatment phase, up-to 8-week extension phase, and up-to 5-day post-treatment phase.

Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Age 6 months - 2 years

Patients between 6 months and 2 years old - Type: Experimental

Group Type EXPERIMENTAL

fexofenadine/Allegra (M016455)

Intervention Type DRUG

Pharmaceutical form:dry syrup formulation to be suspended in water

Route of administration: oral

Age 2 - 11 years

Patients between 2 and 11 years (and under 10.5 kg)

Group Type EXPERIMENTAL

fexofenadine/Allegra (M016455)

Intervention Type DRUG

Pharmaceutical form:dry syrup formulation to be suspended in water

Route of administration: oral

Age 2 - 11 years (and over 10.5 kg)

Patients between 2 and 11 years (and over 10.5 kg)

Group Type EXPERIMENTAL

fexofenadine/Allegra (M016455)

Intervention Type DRUG

Pharmaceutical form:dry syrup formulation to be suspended in water

Route of administration: oral

Interventions

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fexofenadine/Allegra (M016455)

Pharmaceutical form:dry syrup formulation to be suspended in water

Route of administration: oral

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Aged 6 months through 11 years
* Patients with atopic dermatitis

Exclusion Criteria

* Main itching scores are 4 or less than 2 on last three consecutive days before registration.
* Patients who have itching only on face, head, or diaper area.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Minimum Eligible Age

6 Months

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Investigational Site Number 392012

Hitachi-Naka, , Japan

Site Status

Investigational Site Number 392001

Isumi, , Japan

Site Status

Investigational Site Number 392010

Itoshima-Shi, , Japan

Site Status

Investigational Site Number 392002

Katsushika-ku, , Japan

Site Status

Investigational Site Number 392006

Kofu, , Japan

Site Status

Investigational Site Number 392011

Komae-Shi, , Japan

Site Status

Investigational Site Number 392007

Komatsu-Shi, , Japan

Site Status

Investigational Site Number 392003

Kōtoku, , Japan

Site Status

Investigational Site Number 392013

Nagano, , Japan

Site Status

Investigational Site Number 392009

Okayama, , Japan

Site Status

Investigational Site Number 392008

Osaka, , Japan

Site Status

Investigational Site Number 392004

Setagaya-Ku, , Japan

Site Status

Investigational Site Number 392005

Setagaya-Ku, , Japan

Site Status

Countries

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Japan

Other Identifiers

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U1111-1115-4048

Identifier Type: OTHER

Identifier Source: secondary_id

SFY10718

Identifier Type: -

Identifier Source: org_study_id